#1 Clinical Trials Search in Europe

Tepotinib

Tepotinib is an investigational drug being studied in clinical trials for the treatment of various types of cancer, particularly non-small cell lung cancer (NSCLC) with specific genetic alterations. This article summarizes key findings from several clinical trials evaluating tepotinib’s safety, efficacy, and pharmacokinetics in cancer patients and healthy volunteers. The trials explore tepotinib as both a monotherapy and in combination with other drugs for patients with MET gene alterations and other biomarkers.

Table of Contents

What is Tepotinib?

Tepotinib is a targeted cancer therapy drug. It is also known by other names such as MSC2156119J, EMD 1214063, and Tepmetko[9]. Tepotinib belongs to a class of drugs called kinase inhibitors, which work by blocking specific proteins involved in cancer growth[4].

How Tepotinib Works

Tepotinib specifically targets and inhibits a protein called MET (Mesenchymal-epithelial Transition Factor). MET is involved in cell growth and survival. In some cancers, MET can be overactive or altered, leading to uncontrolled cell growth. By blocking MET, Tepotinib aims to slow down or stop the growth of cancer cells[6].

Conditions Treated with Tepotinib

Tepotinib is being studied and used to treat several types of cancer, including:

  • Non-small cell lung cancer (NSCLC): Particularly in patients whose cancer has specific MET alterations, such as MET exon 14 skipping mutations or MET amplification[4][9].
  • Hepatocellular carcinoma (HCC): This is a type of liver cancer[1][8].
  • Other solid tumors: Tepotinib is being investigated for use in various other solid tumors that have MET alterations[9].

How Tepotinib is Administered

Tepotinib is typically given as an oral medication, meaning it is taken by mouth. The most common dosage studied in clinical trials is 500 mg once daily[6][4]. However, the exact dosage may vary depending on the specific condition being treated and individual patient factors. Tepotinib is usually taken in cycles, with each cycle lasting 21 days[1].

Clinical Trials and Research

Tepotinib has been and continues to be studied in various clinical trials. Some key areas of research include:

  • Efficacy in different cancers: Trials are evaluating how well Tepotinib works in treating different types of cancer, particularly those with MET alterations[9].
  • Combination therapy: Some studies are looking at combining Tepotinib with other cancer drugs, such as osimertinib for certain types of lung cancer[6].
  • Brain metastases: Research is being conducted on Tepotinib’s effectiveness in treating cancer that has spread to the brain[7].
  • Comparison with other treatments: Some trials are comparing Tepotinib to other standard treatments, such as sorafenib for liver cancer[8].

Potential Side Effects

Like all medications, Tepotinib can cause side effects. Common side effects reported in clinical trials include:

  • Nausea and vomiting
  • Diarrhea
  • Fatigue
  • Changes in liver function tests
  • Changes in blood cell counts

More serious side effects can occur but are less common. It’s important to discuss potential side effects with your healthcare provider[6][4].

Drug Interactions

Tepotinib may interact with other medications. One study specifically looked at how Tepotinib affects the metabolism of other drugs that are processed by a liver enzyme called CYP3A[5]. This is important because many commonly used medications are processed by this enzyme. Your healthcare provider should be aware of all medications you’re taking to avoid potential interactions.

Aspect Details
Drug Name Tepotinib (also known as MSC2156119J)
Primary Indications NSCLC with MET alterations, hepatocellular carcinoma, solid tumors with MET alterations
Mechanism of Action MET kinase inhibitor
Administration Oral, typically 500 mg daily
Key Efficacy Measures Objective response rate, progression-free survival, overall survival
Safety Assessments Adverse events, laboratory abnormalities, ECG changes, vital signs
Combination Studies With osimertinib in EGFR-mutant NSCLC
Biomarker Analyses MET amplification, MET exon 14 skipping mutations
Quality of Life Measures EQ-5D-5L, EORTC QLQ-C30, NSCLC-SAQ
Pharmacokinetic Studies Drug exposure, metabolism, drug-drug interactions

FAQ

  • What types of cancer is tepotinib being studied for? Tepotinib is primarily being studied for non-small cell lung cancer (NSCLC) with MET gene alterations, including MET exon 14 skipping mutations and MET amplification. It is also being investigated for hepatocellular carcinoma and other solid tumors with MET alterations.
  • How is tepotinib administered? Tepotinib is administered orally, typically as a daily dose of 500 mg. In most trials, it is given as tablets to be taken once daily in 21-day treatment cycles.
  • What are some of the main outcomes being measured in tepotinib clinical trials? Key outcomes include objective response rate, progression-free survival, overall survival, duration of response, and safety/tolerability. Trials are also assessing pharmacokinetics, quality of life measures, and biomarkers of treatment response.
  • Is tepotinib being studied in combination with other drugs? Yes, some trials are evaluating tepotinib in combination with other targeted therapies. For example, it is being studied with osimertinib in NSCLC patients who have developed resistance to EGFR inhibitors.
  • What are some of the potential side effects of tepotinib? Common side effects being monitored include gastrointestinal effects (nausea, vomiting, diarrhea), liver enzyme elevations, and hematological effects like neutropenia and thrombocytopenia. Trials are carefully assessing the safety profile and tolerability of tepotinib.

Ongoing Clinical Trials on Tepotinib

  • Study Comparing Tepotinib to Standard Treatment for Patients with Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness of Tepotinib and Drug Combination for Patients with Advanced Cancer

    Recruiting

    1 1 1
    Investigated drugs:
    Norway

  • Study of Drug Combination for Advanced Cancer Patients with Known Molecular Profile – FINPROVE Study

    Recruiting

    1 1 1
    Investigated drugs:
    Finland

  • Study on the Effectiveness of Entrectinib and Other Drug Combinations for Patients with Advanced Solid Tumors, Multiple Myeloma, or Non-Hodgkin Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effects of Tepotinib and Cetuximab for Patients with Platinum-Resistant Head and Neck Cancer After Immunotherapy Relapse

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Tepotinib and Osimertinib for Patients with Advanced or Metastatic Lung Cancer Resistant to Osimertinib Therapy

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium France Germany Italy Spain

  • Study of Tepotinib for Patients with Advanced Lung Cancer with MET Exon 14 Skipping Alterations or MET Amplification

    Not recruiting

    1 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Poland +1

Glossary

  • MET: A gene that encodes for a protein called hepatocyte growth factor receptor, which is involved in cell growth and survival. Alterations in the MET gene can lead to cancer development and progression.
  • Exon 14 skipping mutation: A specific type of genetic alteration in the MET gene where exon 14 is skipped during RNA splicing, leading to a modified MET protein that can drive cancer growth.
  • NSCLC: Non-small cell lung cancer, a type of lung cancer that accounts for about 80-85% of all lung cancers.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and excreted by the body.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.
  • Tyrosine kinase inhibitor (TKI): A type of targeted therapy that blocks specific enzymes called tyrosine kinases, which are involved in cancer cell growth and survival.

References

  1. https://clinicaltrials.gov/study/NCT02115373
  2. https://clinicaltrials.gov/study/NCT03546608
  3. https://clinicaltrials.gov/study/NCT03629223
  4. https://clinicaltrials.eu/trial/study-of-tepotinib-for-patients-with-advanced-lung-cancer-with-met-exon-14-skipping-alterations-or-met-amplification/
  5. https://clinicaltrials.gov/study/NCT03628339
  6. https://clinicaltrials.eu/trial/study-of-tepotinib-and-osimertinib-for-patients-with-advanced-or-metastatic-lung-cancer-resistant-to-osimertinib-therapy/
  7. https://clinicaltrials.gov/study/NCT05120960
  8. https://clinicaltrials.gov/study/NCT01988493
  9. https://clinicaltrials.gov/study/NCT04647838